Designing clinical and genetic guidelines of colorectal cancer screening as an effective roadmap for risk management.

AIM
We aimed to present clinical and genetic guidelines of colorectal cancer screening for risk assessment of populations at risk.


BACKGROUND
National guidelines can be used as a guide for choosing the method of screening for each individual. These guidelines facilitate decision making and support the delivery of cancer screening service.


METHODS
In the first step, a comparative study was performed by using secondary data extracted from the literature review. Three countries (Canada, Australia and United States) were selected from 25 countries that are member in the International Cancer Screening Network (ICSN). The second step of study was qualitative survey. The study was based on the grounded theory approach. Study tool was semi-structured interview. Interviewing involves asking questions and getting answers from participants. 22 expert's perspectives about guidelines of colorectal cancer screening were surveyed.


RESULTS
Screening program of selected countries was compared. Countries were surveyed by number of risk groups and subgroups, criteria for risk assessment, beginning age, recommendations, screening approaches and intervals. Australia and United States have three risk groups and Canada has two risk groups. Four risk groups were defined in the national guideline, including high risk, increased risk, average and low risk group. The high risk group comprises of 8 subgroups, increased risk group comprises of 3 subgroups and average risk group contain 4 subgroups. Approved clinical criteria for hereditary syndromes and the roadmap of genetic and pathologic survey were designed.


CONCLUSIONS
Guidelines and pathways have a vital role in the quality improvement of CRC screening program. National guidelines were refined according to the environmental and genetic criteria of colorectal cancer in Iran. These guidelines provide evidence-based recommendations by risk groups. National pathways as a risk assessment tool can evaluate and improve the processes and outcomes of cancer screening in practice. One of the suggestions for future research is the designing expert system for real-time decision making during a clinical interaction.


Introduction
care for colorectal cancer screening. These guidelines define and early detect key populations to include both vulnerable and most-at-risk populations (10). However, studies show that multidimensional guidelines can make preventive care services (11). These comprehensive guidelines improve the quality of care and can make clear communication among clinicians (12).
Decision strategiesstrategies for screening have become increasingly complex in recent decades. Screening pathway provide more and new options for cancer management (13).
Special emphasis on the designing of user-friendly referral clinical guidelines, the integrated incorporation of computerbased recall to facilitate risk assessment recommendation is required (14)(15)(16)(17)(18). Key statistics for colorectal cancer have shown several risk factors that might increase a person's chance of developing polyps or CRC (19). The survey of genetic variants and environmental risk may permit individualized risk stratification for CRC as part of routine care. The quality of risk stratification tools has a key role in optimization of screening plan (20). Clinicians and other experts involved in the CRC screening state the need for clear guidance on the risk classification and referral process in clinical practice settings (17,21). We present national risk assessment guidelines for screening plan. Four risk groups were defined, including high risk group, increased group, average and low risk group. These evidence-based clinicalclinical recommendations identify roadmap of detection and removal of adenomatous polyps. CRC largely can be prevented by the early detection of polyps. National guidelines can play an integral role in CRC control by detecting those individuals whose behavior, environment or family history place them at high risk populations. The objective was to provide guidelines for colorectal cancer screening with an emphasis on the care of patients who are at risk for colorectal cancer.

Materials and Methods
In the first stage, a comparative study was conducted by using secondary data extracted from the literature review. Three countries were selected from 25 countries that are member in the international Cancer Screening Network (ICSN). ICSN is a voluntary consortium of countries that have active population-based cancer screening programs and continuing efforts to evaluate and optimize the cancer screening plan in clinical setting (22). Selected countries (Canada, Australia and United States) had clear and comprehensive screening plan by risk groups.
The second stage of study was qualitative survey. The study was based on the grounded theory approach (23). Study tool was semi-structured interview. Interviewing involves asking questions and getting answers from participants. 22 expert' perspectives about guidelines of colorectal cancer screening were surveyed. Participants were informed and had experience about screening program. This sample provided sufficient numbers to ensure exploration of the fields, and data saturation was reached by the final interviews. Participants were asked about number of risk groups and subgroups, criteria for risk assessment, beginning age, recommendations, screening approaches and intervals. All interviews were fully transcribed and coded and analyzed by two researchers. We explained the study and obtained initial consent for further contact from participants. Interviewing involves asking questions and getting answers from participants. We explained the purpose of the study and confidentially of information for participation. Also we asked for consent to audio-record the interviews. Data was gathered by two researchers between January and April 2015. Finally, coded data was organized. All of guidelines were approved by clinical and genetic experts.

Results
Screening program of selected countries (Canada, Australia and United States) was illustrated in table 1. The beginning age for colonoscopic screening was 50 in each three countries (24)(25)(26). Australia and United States have three risk groups and Canada has two risk groups.
Four risk groups were defined in the national guideline, including high risk, increased risk, average and low risk group. The high risk group comprises of 8 subgroups (FAP, AFAP, Suspected FAP, Suspected FAP, HNPCC, Suspected HNPCC, MYH, IBD). Guideline of high risk group was illustrated in figure 1. The increased risk group comprises of 3 subgroups (Personal history of adenoma, Personal history of CRC, Family history of CRC and adenoma). Guideline of increased risk group was illustrated in figure 2. The group of family history of CRC and adenoma contain 5 groups, include one first degree relative with colorectal cancer or adenoma at or before age 60 years, two first degree relative with colorectal cancer or adenoma at any age, one first degree relative with colorectal cancer at age 60 or older, second degree relative with colorectal cancer or adenoma and one first degree relative with adenoma at age 60 years or older. The average risk group comprises of 4 subgroups (Asymptomatic, Negative personal and family history of CRC and adenoma, age 40-57 years/ Rectal bleeding and anemia, Negative personal and family history of CRC and adenoma, age < 40 years/ Rectal bleeding and anemia, Negative personal and family history of CRC and adenoma, age 40-50 years/ Rectal bleeding and anemia, Negative personal and family history of CRC and adenoma, age > 50 years). Guideline of average risk group was illustrated in figure 3. The low risk group comprises of asymptomatic, negative personal and family history of CRC and adenoma, age < 40 years. Guideline of low risk group was illustrated in  Two or more serrated adenoma ≥ 1cm One or two small (<1cm) adenomas or sessile serrated adenoma < 1cm Multiple adenomas (3)(4)(5)(6)(7)(8)(9)(10), larg adenoma ( ≤1cm), adenoma with villous histology, or adenoma with high grade dysplasia.   Rectal bleeding and anemia , Negative personal and family history of CRC and adenoma , age < 40 Rectal bleeding and anemia , Negative personal and family history of CRC and adenoma , age 40 -50 Rectal bleeding and anemia , Negative personal and family history of CRC and adenoma , > 50 Colonoscopy every 10 years/ CT colonography is an option for a failed colonoscopy, flexible sigmoidoscopy every 5 years, if the quality of the bowel preparation is not good, this mandates a repeat procedure at a shorter interval/ Annual FOBT or FIT/ CT colonography every 5 years (does not offer the ability to remove polyps and prevent cancer).
Rectal exam, perianal exam, for recurrent bleeding, consider sigmoidoscopy Colonoscopy (preferred) or sigmoidoscopy If the patient has not had a colonoscopy within the past two years, ordering a colonoscopy, if the patient had a negative colonoscopy within the past two years, consider ordering a flexible sigmoidoscopy or repeat colonoscopy

Discussion
We presented a comparative review of the current literature on screening strategies. This review was basedbased on designing of clinical and genetic guidelines. In this study we defined four risk groups. Screening of HNPCC as a high risk group has relied on analysis of the family history and other clinic-pathological criteria, such as the Amsterdam and Bethesda criteria (27). Individuals with suspected HNPCC were detected by clinical criteria in the first step. Approved guidelines contain two clinical criteria, including Amsterdam and Bethesda criteria. Predictive examination of HNPCC is conducted within genetic counseling protocol (28). National guidelines covered roadmap of counseling protocol. Health care professionals are involved in CRC screening program suggested indicators for quality improvementimprovement of the pilot CRC plans (29). This survey details all of criteria and indicators for risk assessment. Emphasis on the golden standards is significant for implementing of screening plans (30). The outcomes of population-based screening programs have shown colonoscopy is a prevention tool against colorectal cancer (31). We present colonoscopy as a prevention tool especially among high risk populations. In addition, Screening for CRC is a complex process (32,33). User-friendly referral clinical guidelines facilitate this complex process by recognized recommendations (14)(15)(16)(17)(18). This document includes comprehensive and clear guidelines for risk stratification that help healthcare professionals to better detect the colorectal cancer at an early stage. Studies show that adenoma detection to reduce CRC rates (34). Formulated national guidelines were classify polyps and recommended appropriate screening methods for investigating of polyps. Individuals with personal and family history of adenoma were classified by guidelines. According to our current studies, 75% of diagnosed CRC are sporadic (35). In this survey, individuals with familial/inherited and sporadic colon cancer were classified separately. Screening approaches were defined for sporadic colon cancer and demonstrated in guideline structure. International guidelines suggest the idea of colonoscopy surveillance after detection and removal of polyps (36). National guidelines interpreted colonoscopy interval and other criteria after removal of polyps in covered populations. According to these studies, it is accepted that organized guidelines facilitate colorectal cancer screening.
In summary, clinical and genetic guidelines have a key role in quality improvement of CRC screening. National guidelines were refined according to the environmental and genetic criteria of colorectal cancer in Iran. These guidelines provide evidence-based recommendations by risk groups. National pathways as a risk assessment tool can evaluate and improve the processes and outcomes from cancer screening in practice. Screening guidelines need to be integrated with clinical process for providing suitable patient-specific advice. Considering to results of this study is useful for optimaloptimal implementing of a risk assessment system. As a conclusion, it is recommended to consider the necessity of integration standards for risk assessment.
One of the suggestions for future research is to design an intelligent system for real-time decision making during